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TERBUTALINE’s SAFETY AND EFFICACY FOR TOCOLYSIS

Executive Summary

TERBUTALINE's SAFETY AND EFFICACY FOR TOCOLYSIS will be the subject of discussion by FDA's Fertility & Maternal Health Drugs Advisory Committee May 20. Terbutaline (Ciba-Geigy's Brethine and Marion Merrell Dow's Brecanyl) is used off-label for the prevention of preterm labor. Astra's Yutopar (ritodrine) has approved labeling for that indication. At an advisory committee last November that reaffirmed ritodrine's usefulness in a subset of the preterm labor population, the committee took note of databases and research articles discussing the use of terbutaline for tocolysis and expressed willingness to review the drug for that indication if a supplemental, literature-based NDA were filed ("The Pink Sheet" Nov. 2, 1992, p. 4). No NDA will be reviewed at the upcoming meeting, however. On May 21, the committee will discuss a request from Planned Parenthood to revise oral contraceptive labeling "to reflect current practice of conducting physical exams after medication has been started." Both sessions of the advisory committee meeting are scheduled to be held at the agency's Parklawn Building, Conference Rooms D & E beginning both days at 9 a.m.
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